Infant ALLNCT05393128
The Effect of Different Positions in Children After Cardiac Surgery
A study testing Experimental Group (Right Lateral position) and Experimental Group (Left Lateral position) in people with Infant ALL, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study to determine the effects of giving right lateral, left lateral and supine positions on vital signs and oxygen saturation in children after cardiac surgery. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Infant ALL
- What is being tested?
- Experimental Group (Right Lateral position) and Experimental Group (Left Lateral position)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- First time experiencing congenital cardiovascular surgery,
- Having Bilateral pulmonary atelectasis assessment,
- Not having any secondary congenital anomaly or chronic disease,
- Not having any neurologic symptoms,
- Being between 1 month - 1 year old
- Not having bilateral circulatory disorder and not having any obstacle to the position,
- Being Intubated
- Receiving 1 mg/kg dormicum, 0,1 mcg/kg fentaver infusion
Who cannot join
- Receiving Extra Corporal Membrane Exygenation support,
- Admitted to ICU with sternum exposed,
- Receiving Intraaortic balloon pump support,
- Being a Pre-op period patient,
- Having a non-bilateral circulatory disorder,
- Having unilateral thorax drain,
Show all 9Show fewer
- Being extubated or being planned for extubation during the study period,
- Receiving Rocuranium,
- Not receiving Dormicum or fentaver
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Education and Research Hospital
Istanbul, Kadıköy, 34734
About this study
Official title: The Effect of Different Positions in Children After Cardiac Surgery On Vital Signs And Oxygen Saturation
The objective of this study to determine the effects of giving right lateral, left lateral and supine positions on vital signs and oxygen saturation in children after cardiac surgery.
Read the detailed description
Convenient ventilation management after pediatric cardiac surgery and the positioning of the patient helps to reduce the maximum intrathoracic pressure and venous stasis of the trunk and upper extremities that facilitates the drainage of the blood in the lungs. Due to the fact that the Pre-operative and post-operative management has tremendously changed for the last years, more detailed and up-to-date information is required related to the effect of the body position on the changes of the lung capacities and the pulmonary function. Based on this reason, this research was designed to determine the effect of three different positions as a randomized controlled prospective study.
In case the unit does not contain as routine any obstacle for position (unilateral oedema, ciculation disorder in the extremities, non-bilateral pulmonary atelectasis or dense infiltration, patients who cannot be administered dormicum or fentaver) right lateral, left lateral and supine positions are given. First positioning; also in routine, the standart position given to the first patients is supine position. The patient is first placed supine. Then his arms and legs are supported with support pillows. Transducer level and cuff pressure are controlled, SpO2 probe, ECG probes are controlled. If there's CVK connection, if there isn't any arterial connection, the cuff is controlled and in order to avoid heat loss the patient is covered after controling the body temperature and the position is completed.
In positioning, the 2nd method is right lateral positioning. In this positioning, the patient bed is straightened. Later on, the patient's SpO2 probe, ECG probes, CVK, arterial and cuff connections are once again moved to the right side of the patient and moved from below the patient's body without contact with the body in order to ensure the connections. Then, the patient is turned to right side with angle of 60 or 90 degrees and back is supported with a pillow from the neck to his sacrum, between the legs is also supported with a pillow. Afterwards, the patient's head is elevated with 45 to 60 degrees. Body temperature is controlled. The body is covered in order to avoid temperature loss and position is completed.
The third position that is used is left lateral position. In this positioning, the patient bed is straightened. Then, the patient's SpO2 probe, ECG probe, CVK, artery and cuff connections are transferred to the left side and the connections are made by passing the connections from below the pillow of the patient without touching the body. Later on, The patient is turned to left side with angle of 60 or 90 degrees to the left and the patient's back is supported with pillow from the neck until the sacrum, between the legs is again covered with a pillow. After that, the patient's head is elevated with 45-60 degrees. Body temperature is controlled, covered in order to avoid temperature loss and position is completed.
In this unit, after performing the applications related to the method used, the patient's vital signs and SpO2 are checked and recorded every half hour in the postoperative 24 hours, and hourly in the following processes.
In this study, implementation and data collection for each group will begin after the patient is admitted to the intensive care unit, after stabilization of the surgery (after the 12th hour). Until this time, the patient's follow-up is done in supine position. After stabilization, with the cooperation of the physician, it will continue to be supported by the right lateral and left lateral positions in addition to the supine position every 2 hours. Vital signs and SpO2 values of the patient will be recorded just before positioning, at the 1st minute, 1st hour and its 2nd hour after positioning.
- Conditions
- Infant ALL
- Being tested
- Control group (Supine Position), Experimental Group (Right Lateral position), Experimental Group (Left Lateral position)
- Keywords
- pediatric heart surgery, position, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (Supine Position)Procedure or surgery
In this group the patients will be given supine position.
- Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process.
- The patient will be given supine position.
- The arms and the hands will be elevated and supported, the legs will be elevated and supported.
- The patient will be covered.
- The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.
Experimental Group (Right Lateral position)Procedure or surgery
In this group the patients will be given right lateral position.
- Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process.
- The patient will be positioned supine and the bed will be straightened.
- Lines, probes will be taken to the right side of the patient and the patient will be turned with 60-90 degrees right lateral and the back will be supported with a pillow along the neck and sacrum.
- Between the legs will be supported with pillows.
- The patient's head will be elevated with 45-60 degrees.
- The patient will be covered :
- The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.
Experimental Group (Left Lateral position)Procedure or surgery
In this group the patients will be given left lateral position.
- Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process.
- The patient will be positioned supine and the bed will be straightened.
- Lines, probes will be taken to the left side of the patient and the patient will be turned with 60-90 degrees left lateral and the back will be supported with a pillow along the neck and sacrum.
- Between the legs will be supported with pillows.
- The patient's head will be elevated with 45-60 degrees.
- The patient will be covered :
- The patient's vital findings, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Supine position) | Other | The patient will remain in the supine position for 2 hours and will be followed up with the physician and nurse.
After the patient is given one of the supine position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change. Receives: Procedure: Control group (Supine Position) |
| Experimental Group (Right lateral position) | Experimental | The patient will remain in the right lateral position for 2 hours and will be followed up with the physician and nurse.
After the patient is given one of the right lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change. Receives: Procedure: Experimental Group (Right Lateral position) |
| Experimental Group (Left lateral position) | Experimental | The patient will remain in the left lateral position for 2 hours and will be followed up with the physician and nurse.
After the patient is given one of the left lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change. Receives: Procedure: Experimental Group (Left Lateral position) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Temperature
This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary.
Measured: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Change in Heart Rate
Heart rate will be monitored.
Measured: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Change in Blood Pressure
Blood Pressure will be monitored.
Measured: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Change in Respiratory Rate
Respiratory rate will be monitored.
Measured: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Change in Oxygen Saturation
Oxygen Saturation will be monitored.
Measured: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start17 Mar 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infant ALLStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Zehra Kan Öntürk, Assist Prof, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393128
- Sponsor's protocol ID
- ATADEK-2021/21
- Status last verified
- Dec 2023
- First submitted
- 2 Mar 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva ME, Feuser MR, Silva MP, Uhlig S, Parazzi PL, Rosa GJ, Schivinski CI. Pediatric cardiac surgery: what to expect from physiotherapeutic intervention? Rev Bras Cir Cardiovasc. 2011 Apr-Jun;26(2):264-72. doi: 10.1590/s0102-76382011000200018. English, Portuguese.
PubMed 21894418Thomas PJ, Paratz JD. Is there evidence to support the use of lateral positioning in intensive care? A systematic review. Anaesth Intensive Care. 2007 Apr;35(2):239-55. doi: 10.1177/0310057X0703500214.
PubMed 17444315de Laat E, Schoonhoven L, Grypdonck M, Verbeek A, de Graaf R, Pickkers P, van Achterberg T. Early postoperative 30 degrees lateral positioning after coronary artery surgery: influence on cardiac output. J Clin Nurs. 2007 Apr;16(4):654-61. doi: 10.1111/j.1365-2702.2006.01715.x.
PubMed 17402946Hickey PA, Pasquali SK, Gaynor JW, He X, Hill KD, Connor JA, Gauvreau K, Jacobs ML, Jacobs JP, Hirsch-Romano JC. Critical Care Nursing's Impact on Pediatric Patient Outcomes. Ann Thorac Surg. 2016 Oct;102(4):1375-80. doi: 10.1016/j.athoracsur.2016.03.019. Epub 2016 May 10.
PubMed 27173065
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Positions in Children After Cardiac Surgery On Vital Signs And Oxygen Saturation
- ClinicalTrials.gov ID
- NCT05393128
- Acronym / sponsor ID
- ATADEK-2021/21
- Conditions
- Infant ALL
- Keywords
- pediatric heart surgery, position, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study to determine the effects of giving right lateral, left lateral and supine positions on vital signs and oxygen saturation in children after cardiac surgery.
Detailed description
Convenient ventilation management after pediatric cardiac surgery and the positioning of the patient helps to reduce the maximum intrathoracic pressure and venous stasis of the trunk and upper extremities that facilitates the drainage of the blood in the lungs. Due to the fact that the Pre-operative and post-operative management has tremendously changed for the last years, more detailed and up-to-date information is required related to the effect of the body position on the changes of the lung capacities and the pulmonary function. Based on this reason, this research was designed to determine the effect of three different positions as a randomized controlled prospective study.
In case the unit does not contain as routine any obstacle for position (unilateral oedema, ciculation disorder in the extremities, non-bilateral pulmonary atelectasis or dense infiltration, patients who cannot be administered dormicum or fentaver) right lateral, left lateral and supine positions are given. First positioning; also in routine, the standart position given to the first patients is supine position. The patient is first placed supine. Then his arms and legs are supported with support pillows. Transducer level and cuff pressure are controlled, SpO2 probe, ECG probes are controlled. If there's CVK connection, if there isn't any arterial connection, the cuff is controlled and in order to avoid heat loss the patient is covered after controling the body temperature and the position is completed.
In positioning, the 2nd method is right lateral positioning. In this positioning, the patient bed is straightened. Later on, the patient's SpO2 probe, ECG probes, CVK, arterial and cuff connections are once again moved to the right side of the patient and moved from below the patient's body without contact with the body in order to ensure the connections. Then, the patient is turned to right side with angle of 60 or 90 degrees and back is supported with a pillow from the neck to his sacrum, between the legs is also supported with a pillow. Afterwards, the patient's head is elevated with 45 to 60 degrees. Body temperature is controlled. The body is covered in order to avoid temperature loss and position is completed.
The third position that is used is left lateral position. In this positioning, the patient bed is straightened. Then, the patient's SpO2 probe, ECG probe, CVK, artery and cuff connections are transferred to the left side and the connections are made by passing the connections from below the pillow of the patient without touching the body. Later on, The patient is turned to left side with angle of 60 or 90 degrees to the left and the patient's back is supported with pillow from the neck until the sacrum, between the legs is again covered with a pillow. After that, the patient's head is elevated with 45-60 degrees. Body temperature is controlled, covered in order to avoid temperature loss and position is completed.
In this unit, after performing the applications related to the method used, the patient's vital signs and SpO2 are checked and recorded every half hour in the postoperative 24 hours, and hourly in the following processes.
In this study, implementation and data collection for each group will begin after the patient is admitted to the intensive care unit, after stabilization of the surgery (after the 12th hour). Until this time, the patient's follow-up is done in supine position. After stabilization, with the cooperation of the physician, it will continue to be supported by the right lateral and left lateral positions in addition to the supine position every 2 hours. Vital signs and SpO2 values of the patient will be recorded just before positioning, at the 1st minute, 1st hour and its 2nd hour after positioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (Supine position) | Other | Procedure: Control group (Supine Position)The patient will remain in the supine position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the supine position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change. |
| Experimental Group (Right lateral position) | Experimental | Procedure: Experimental Group (Right Lateral position)The patient will remain in the right lateral position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the right lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change. |
| Experimental Group (Left lateral position) | Experimental | Procedure: Experimental Group (Left Lateral position)The patient will remain in the left lateral position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the left lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- First time experiencing congenital cardiovascular surgery,
- Having Bilateral pulmonary atelectasis assessment,
- Not having any secondary congenital anomaly or chronic disease,
- Not having any neurologic symptoms,
- Being between 1 month - 1 year old
Key exclusion criteria (9 listed)
- Receiving Extra Corporal Membrane Exygenation support,
- Admitted to ICU with sternum exposed,
- Receiving Intraaortic balloon pump support,
- Being a Pre-op period patient,
- Having a non-bilateral circulatory disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group (Supine Position)In this group the patients will be given supine position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be given supine position. 3. The arms and the hands will be elevated and supported, the legs will be elevated and supported. 4. The patient will be covered. 5. The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position. | Procedure or surgery | Control group (Supine position) |
| Experimental Group (Right Lateral position)In this group the patients will be given right lateral position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be positioned supine and the bed will be straightened. 3. Lines, probes will be taken to the right side of the patient and the patient will be turned with 60-90 degrees right lateral and the back will be supported with a pillow along the neck and sacrum. 4. Between the legs will be supported with pillows. 5. The patient's head will be elevated with 45-60 degrees. 6. The patient will be covered : 7. The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position. | Procedure or surgery | Experimental Group (Right lateral position) |
| Experimental Group (Left Lateral position)In this group the patients will be given left lateral position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be positioned supine and the bed will be straightened. 3. Lines, probes will be taken to the left side of the patient and the patient will be turned with 60-90 degrees left lateral and the back will be supported with a pillow along the neck and sacrum. 4. Between the legs will be supported with pillows. 5. The patient's head will be elevated with 45-60 degrees. 6. The patient will be covered : 7. The patient's vital findings, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position. | Procedure or surgery | Experimental Group (Left lateral position) |
Primary outcome
Change in Body Temperature
Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary.
Change in Heart Rate
Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Heart rate will be monitored.
Change in Blood Pressure
Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Blood Pressure will be monitored.
Change in Respiratory Rate
Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Respiratory rate will be monitored.
Change in Oxygen Saturation
Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Oxygen Saturation will be monitored.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Results publication: PubMed 21894418Silva ME, Feuser MR, Silva MP, Uhlig S, Parazzi PL, Rosa GJ, Schivinski CI. Pediatric cardiac surgery: what to expect from physiotherapeutic intervention? Rev Bras Cir Cardiovasc. 2011 Apr-Jun;26(2):264-72. doi: 10.1590/s0102-76382011000200018. English, Portuguese.
- Results publication: PubMed 17444315Thomas PJ, Paratz JD. Is there evidence to support the use of lateral positioning in intensive care? A systematic review. Anaesth Intensive Care. 2007 Apr;35(2):239-55. doi: 10.1177/0310057X0703500214.
- Results publication: PubMed 17402946de Laat E, Schoonhoven L, Grypdonck M, Verbeek A, de Graaf R, Pickkers P, van Achterberg T. Early postoperative 30 degrees lateral positioning after coronary artery surgery: influence on cardiac output. J Clin Nurs. 2007 Apr;16(4):654-61. doi: 10.1111/j.1365-2702.2006.01715.x.
- Results publication: PubMed 27173065Hickey PA, Pasquali SK, Gaynor JW, He X, Hill KD, Connor JA, Gauvreau K, Jacobs ML, Jacobs JP, Hirsch-Romano JC. Critical Care Nursing's Impact on Pediatric Patient Outcomes. Ann Thorac Surg. 2016 Oct;102(4):1375-80. doi: 10.1016/j.athoracsur.2016.03.019. Epub 2016 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehra Kan Öntürk, Assist Prof principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (Right Lateral position) and Experimental Group (Left Lateral position) in people with Infant ALL, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Temperature (time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393128, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.